| CTRI Number |
CTRI/2021/04/033140 [Registered on: 27/04/2021] Trial Registered Prospectively |
| Last Modified On: |
26/04/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Prevalence of Hypomagnesemia among Alcohol Dependent Males admitted under Psychiatry and also among Non Alcohol Dependent Males in Medicine OP |
|
Scientific Title of Study
|
Prevalence of Hypomagnesemia among Alcohol Dependents admitted under Psychiatry Department(Cases) Prevalence of Hypomagnesemia among Non Alcohol Dependent Male Subjects coming to Medicine OPD between the age of 20-60 years(Controls) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Angela Jacob |
| Designation |
Medical Student |
| Affiliation |
MOSC Medical College,Kolencherry,Cochin |
| Address |
Kannavil,Anandapally Post,Adoor,Pathanamthitta
Undergraduate medical student,MOSC MBBS Batch of 2017,Womens hostel,MOSC Medical College
Ernakulam
KERALA
681525
India |
| Phone |
6238624229 |
| Fax |
|
| Email |
angelaannjacob@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
T George Koshy |
| Designation |
Associate Professor |
| Affiliation |
MOSC Medical College, Kolencherry |
| Address |
Department of General Medicine,MOSCC kOLENCHERRY
MOSC Medical College
Kolencherry
Ernakulam
KERALA
682311
India |
| Phone |
09633446430 |
| Fax |
|
| Email |
dsgkoshy@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
T George Koshy |
| Designation |
Associate Professor |
| Affiliation |
MOSC Medical College, Kolencherry |
| Address |
Department of General Medicine,MOSCC kOLENCHERRY
MOSC Medical College
Kolencherry
Ernakulam
KERALA
682311
India |
| Phone |
09633446430 |
| Fax |
|
| Email |
dsgkoshy@gmail.com |
|
|
Source of Monetary or Material Support
|
| MOSC Medical college,Kolencherry |
|
|
Primary Sponsor
|
| Name |
MOSC Medical College |
| Address |
Kolencherry,Ernakulam 682311.Kerala.India |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| T George Koshy |
MOSC Medical College Kolencherry |
Psychiatry and Deaddiction wards and Medicine Outpatient Department
Ernakulam
KERALA |
09633446430
dsgkoshy@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MOSC Medical College IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
adult males between 20 to 60 years who are NOT DEPENDENT on alcohol ,who do not have features of hypothyroidism or malabsorption |
| Patients |
(1) ICD-10 Condition: E639||Nutritional deficiency, unspecified, |
|
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Intervention / Comparator Agent
|
|
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Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Male |
| Details |
Features of alcohol dependence based on CAGE questionnaire: C-have u ever felt the need to cut down on your alcohol intake/A -have u been Annoyed by other people criticizing you about your alcohol intake?/G- have u ever felt guilty about your alcohol intake/E -have u ever needed to take alcohol first thing in the morning as an eyeopener?
No hypothyroidism
No features of malabsorption |
|
| ExclusionCriteria |
| Details |
Nonalcoholic male
Features of hypothyroidism
Features of intestinal malabsorption |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To estimate prevalence of hypomagnesemia among alcohol dependent patients in Psychiatry and compare that to prevalence of hypomagnesmia amomg non alcohol dependent subjects in General Medicine OP |
one year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study effect of magnesium replacement on subjects with alcohol dependence who are magnesium deficient |
one year |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
03/05/2021 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Study is planned for a period of one year,publication will be decided once data collection is over |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [dsgkoshy@gmail.com].
- For how long will this data be available start date provided 04-05-2023 and end date provided 04-05-2028?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Alcohol dependence is a rampant social problem in our community with widespread health ramifications in terms of central nervous system effects including dementia, alcohol withdrawal. delirium tremens,Wernicke’s encephalopathy, Korsacoff’s psychosis and seizures ,peripheral nervous system including loss of sensation as well as burning pain and tingling sensations and paresthesias and profound effects on the liver function as well. Delirium tremens is associated with hypomagnesemia, hypocalcemia, hypophosphatemia, metabolic acidosis, and respiratory alkalosis of which the commonest is hypomagnesemia. We aim to estimate the prevalence of hypomagnesemia among 100 subjects admitted with features of alcohol dependence and treat it if present and compare that with the prevalence of hypomagnesemia among 100 non-alchol dependent controls attending the Medicine OP. We hope we can evolve guidelines where we look for hypomagnesemia among all alcohol dependent subjects as a rule. Alcohol dependence is decided based on the CAGE questionnaire:C-have u ever felt the need to CUT down on your alcohol intake,A-have people annoyed you by criticising you on your alcohol intake,G-have you ever felt Guilty about it,E-have you ever needed to take a drink first thing in the morning as an EYE OPENER?.Serum magnesium below 1.6 mg% is taken as hypomagnesemia |